Trial · NCT01976728
LutrePulse Hypogonadotropic Hypogonadism
NCT01976728, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2021-03-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. LutrePulse Hypogonadotropic Hypogonadism. Trials, record NCT01976728. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01976728
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LutrePulse Hypogonadotropic Hypogonadism
- NCT number
- NCT01976728
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 39 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Primary Amenorrhea With Hypogonadotropic Hypogonadism
- Interventions
Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump, Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump, Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump, Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)
- First posted
- 2013-11-06
- Last updated
- 2021-03-03
- Results first posted
- 2021-03-03
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ovulation Rate | From treatment Day 1 up to 4 weeks after second positive β-hCG test, approximately 9 weeks | Calculated as a proportion of subjects with at least 1 post-baseline progesterone level ≥ 6 ng/mL or subjects with confirmed positive serum β-human chorionic gonadotropin (β-hCG) (i.e., 2 positive results) or subjects with a gestational sac documented by transvaginal ultrasound (TVUS). |
| Secondary | Progesterone (P4) Levels | Treatment Days 19, 21, 23, 25, and 27 | Proportion of participants with at least 1 post-baseline P4 level ≥ 10 ng/mL. |
| Secondary | Clinical Pregnancy Rate | 2 to 4 weeks after a second positive serum β-hCG test | Proportion of subjects with presence of gestational sac and fetal heart movement on TVUS after a second positive serum β-hCG test. |
| Secondary | Biochemical Pregnancy Rate | Approximately 14 days after LH surge | Proportion of subjects with a confirmed positive serum β-hCG test after luteinizing hormone (LH) surge. |
| Secondary | LH Surge Detection | Daily from Day 11 until first positive LH surge or until Day 39 | Proportion of subjects with a positive detection of LH surge, based on a Clearblue test which began when follicles with a mean diameter ≥14 mm were documented on TVUS. |
| Secondary | Ovarian Follicular Development: Number of Follicles With a Mean Diameter Greater Than or Equal to (≥)14 mm | From treatment Day 10 to treatment Day 21 | Number of follicles with a mean diameter ≥14 mm collected from Days 10 or 11, until LH surge or Day 21. |
| Secondary | Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm | From treatment Day 10 to treatment Day 21 | Number of dominant follicles with a mean diameter ≥18 mm collected from Days 10 or 11, until LH surge or Day 21. |
| Secondary | Luteal Phase Support: Maximum P4 Levels | Treatment Days 19, 21, 23, 25, and 27 | Maximum of post-dose P4 levels collected on treatment Days 19 to 27 are presented. |
| Secondary | Luteal Phase Support: Mean P4 Levels | Median post-dose P4 values across Treatment Days 19, 21, 23, 25, and 27 | Mean of post-dose P4 levels collected on treatment Days 19 to 27 are presented. |
| Secondary | Change From Baseline in Follicle-stimulating Hormone (FSH) | Baseline (pre-dose), Treatment Day 1, Treatment Day 10 | FSH change from baseline in relation to the first dose (pulse) on Day 1 and Day 10 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ovulation Rate | From treatment Day 1 up to 4 weeks after second positive β-hCG test, approximately 9 weeks | The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progesterone (P4) Levels | Treatment Days 19, 21, 23, 25, and 27 | The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Pregnancy Rate | 2 to 4 weeks after a second positive serum β-hCG test | The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Biochemical Pregnancy Rate | Approximately 14 days after LH surge | The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | LH Surge Detection | Daily from Day 11 until first positive LH surge or until Day 39 | The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Ovarian Follicular Development: Number of Follicles With a Mean Diameter Greater Than or Equal to (≥)14 mm | From treatment Day 10 to treatment Day 21 | The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9). | follicles | MEDIAN |
| SECONDARY | Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm | From treatment Day 10 to treatment Day 21 | The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9). | follicles | MEDIAN |
| SECONDARY | Luteal Phase Support: Maximum P4 Levels | Treatment Days 19, 21, 23, 25, and 27 | The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9). | ng/mL | MEDIAN |
| SECONDARY | Luteal Phase Support: Mean P4 Levels | Median post-dose P4 values across Treatment Days 19, 21, 23, 25, and 27 | The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9). | ng/mL | MEDIAN |
| SECONDARY | Change From Baseline in Follicle-stimulating Hormone (FSH) | Baseline (pre-dose), Treatment Day 1, Treatment Day 10 | The full analysis set (FAS) comprised all randomized subjects who were included in ITT analysis set and had received at least 14 days of investigational medicinal product (IMP). One subject in the LutrePulse 10 µg/Pulse group was discontinued from the trial after 6 days exposure and is not included in the FAS (LutrePulse 10 µg/Pulse: n=9). | IU/L | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group165
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ovulation Rate | LutrePulse 10 µg/Pulse | 1 | Participants | ||
| Ovulation Rate | LutrePulse 15 µg/Pulse | 4 | Participants | ||
| Ovulation Rate | LutrePulse 20 µg/Pulse | 5 | Participants | ||
| Ovulation Rate | Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled | 9 | Participants | ||
| Ovulation Rate | Placebo | 0 | Participants | ||
| Progesterone (P4) Levels | LutrePulse 10 µg/Pulse | 1 | Participants | ||
| Progesterone (P4) Levels | LutrePulse 15 µg/Pulse | 4 | Participants | ||
| Progesterone (P4) Levels | LutrePulse 20 µg/Pulse | 3 | Participants | ||
| Progesterone (P4) Levels | Lutrepulse 15 μg/Pulse and 20 μg/Pulse Pooled | 7 | Participants | ||
| Progesterone (P4) Levels | Placebo | 0 | Participants |
1 to 10 of 165Source ClinicalTrials.gov
See all 165 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LutrePulse 10 µg/Pulse | 10 | |
| Overall Study | STARTED | LutrePulse 15 µg/Pulse | 9 | |
| Overall Study | STARTED | LutrePulse 20 µg/Pulse | 10 | |
| Overall Study | STARTED | Placebo | 10 | |
| Overall Study | Dosed | LutrePulse 10 µg/Pulse | 10 | |
| Overall Study | Dosed | LutrePulse 15 µg/Pulse | 9 | |
| Overall Study | Dosed | LutrePulse 20 µg/Pulse | 10 | |
| Overall Study | Dosed | Placebo | 10 | |
| Overall Study | COMPLETED | LutrePulse 10 µg/Pulse | 9 | |
| Overall Study | COMPLETED | LutrePulse 15 µg/Pulse | 9 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events124
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | LutrePulse 10 µg/Pulse | 0 | 10 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | LutrePulse 15 µg/Pulse | 0 | 8 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | LutrePulse 20 µg/Pulse | 1 | 10 | 1 |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 0 | 11 | 0 |
| other | Abdominal distesion | Gastrointestinal disorders | LutrePulse 10 µg/Pulse | 0 | 10 | 0 |
| other | Abdominal distesion | Gastrointestinal disorders | LutrePulse 15 µg/Pulse | 0 | 8 | 0 |
| other | Abdominal distesion | Gastrointestinal disorders | LutrePulse 20 µg/Pulse | 1 | 10 | 1 |
| other | Abdominal distesion | Gastrointestinal disorders | Placebo | 1 | 11 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | LutrePulse 10 µg/Pulse | 0 | 10 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | LutrePulse 15 µg/Pulse | 0 | 8 | 0 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LutrePulse 10 µg/Pulse | 0 | 10 |
| Total, all-cause mortality | LutrePulse 15 µg/Pulse | 0 | 8 |
| Total, all-cause mortality | LutrePulse 20 µg/Pulse | 0 | 10 |
| Total, all-cause mortality | Placebo | 0 | 11 |
| Total, other adverse events | LutrePulse 10 µg/Pulse | 5 | 10 |
| Total, other adverse events | LutrePulse 15 µg/Pulse | 3 | 8 |
| Total, other adverse events | LutrePulse 20 µg/Pulse | 4 | 10 |
| Total, other adverse events | Placebo | 4 | 11 |
| Total, serious adverse events | LutrePulse 10 µg/Pulse | 0 | 10 |
| Total, serious adverse events | LutrePulse 15 µg/Pulse | 0 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01976728
GET https://conductscience.org/api/trials/v1/NCT01976728/results?page=2